BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton

GUDID 00850005949350

BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton

BIOINTELLISENSE, INC.

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 00850005949350
• NIH Device Record Key: 70af72a1-1168-4c85-b823-e2d1cf49e5d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton
• Version Model Number: KIT-BBR-3763-3
• Company DUNS: 116984478
• Company Name: BIOINTELLISENSE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005949343 [Primary]
GS1	00850005949350 [Package]; Contains: 00850005949343; Package: Master Carton (MC) [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212957

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by BIOINTELLISENSE, INC.

• 00850005949466 - BioDashboard: 2025-03-10 BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data a
• 10850005949555 - BioButton (Reprocessed): 2025-02-27 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
• 10850005949562 - BioButton (Reprocessed, NF Version): 2025-02-27 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
• 10850005949593 - BioButton Charging Station: 2025-02-27 The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearab
• 10850005949449 - BioButton Rechargeable Device, Multi-Patient: 2025-02-19 The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological
• 00850005949534 - BioButton Adhesive V2 (ADH-CS): 2024-05-09 BioButton Cold Seal Adhesive V2 (ADH-CS)
• 00850005949336 - BioButton At-Home Kit with Power Adaptor: 2023-11-24 BioButton At-Home Kit with Power Adaptor
• 00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton: 2023-11-24BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton
• 00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton: 2023-11-24 BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton